PROJECT SUMMARY/ABSTRACT ? EARLY PHASE CLINICAL RESEARCH SUPPORT Early phase clinical research is important for the advancement of FCCC science as it translates into humans at risk for or carrying a cancer diagnosis. Over the prior funding period, four clinical trials were supported with EPCRS funding with 53 accruals; support was not provided for correlative studies associated with these trials. Additional funds from FCCC for early phase study clinical research have supported the conduct of 2 trials as well as the cost of correlative genomic profiling; to date these studies have accrued 75 patients. The process for evaluating and prioritizing funding for Early Phase Clinical Research Support (EPCRS) has been revised to prioritize and fund proposals that support the scientific goals of the institution and needs of our catchment area. To do so, Translational Research Disease Groups (TRDG) have been formed, allowing disease research to be articulated and assisting in spanning research directions from the bench to bedside. In addition, we have assembled the EPCRS review committee to assess projects for funding, including leadership from the Molecular Therapeutics Program and the Phase I program at FCCC. The long range objectives are to fund clinical research that supports the research priorities of FCCC, address diseases that are of particular interest within the FCCC catchment area, and/or which directly develop from FCCC scientific research. Successful use of EPCRS will be determined by the following metrics: 1) completion accrual to studies within 24 months; 2) peer-reviewed publications; 3) development of the concept for testing beyond phase I with support of additional studies by grant, industry or cooperative group funding.